Physiological Effects of Stevia Consumption in Humans (NCT03993418) | Clinical Trial Compass
CompletedNot Applicable
Physiological Effects of Stevia Consumption in Humans
United Kingdom30 participantsStarted 2019-02-01
Plain-language summary
This study will evaluate whether long-term consumption of the low calorie sweetener stevia affects glucose tolerance in healthy participants. With regard to this aim, we will recruit 2 study groups, the stevia group where participants will be required to add stevia drops twice daily in their habitual drinks and the control group where participants will be asked not to change anything in their diet and lifestyle.
Who can participate
Age range18 Years – 40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-40 years
* BMI 18.5-25 kg/m2
* No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week)
* DEBQ for restraint eating ≤ 3
* Healthy - general good health
* Not taking medications that affect metabolism or appetite (i.e. thiazide diuretics, glucocorticoids or beta blockers)
* Stable weight, ≤ 5 kg last 12 months
* Fasting blood glucose ≤6.0 mmol/L
* Willing to comply with the study protocol
* No self-reported food allergy or intolerance to foods supplied during the study
* The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* The participant is able to read, comprehend and record information written in English.
* A signed and dated written informed consent is obtained from the participant.
Exclusion Criteria:
* Age under 18 years or over 40 years old.
* BMI \>25 kg/m2 and \<18.5kg/m2
* Participants who are not willing to comply with study procedures (including expression of dislike for NNS)
* Habitual NNS consumers, \>1 can of diet beverage or \>1 sachet of low calorie sweeteners per week.
* Fasting blood glucose measured \> 6 mmol/L
* Subjects who are currently dieting and having ceased a diet in \< 4 weeks
* DEBQ score for restraint eating \> 3
* Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.
* Ve…
What they're measuring
1
Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC)